BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPUR® II INFANT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR

    MDR report key: 6913976 · Received October 4, 2017

    Report

    Report Number
    6913976
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    August 22, 2017
    Report Date
    September 14, 2017
    Manufacturer
    AMBU A/S
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO BROKEN AMBU BAGS WERE FOUND IN THE OPERATING ROOM SPACE. THE AMBU BAGS APPEAR TO HAVE BROKEN WHERE THE VALVE ATTACHES TO THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693466 SPUR® II INFANT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM AMBU A/S 544200047 1861681

    Patients

    Seq Age Sex Outcome Treatment
    1